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AstraZeneca's Breast Cancer Candidate BLA Gets Priority Review

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AstraZeneca (AZN - Free Report) and its Japanese partner Daiichi Sankyo Company announced that the FDA has granted priority review to the biologics license application (“BLA”) for their antibody drug conjugate candidate, trastuzumab deruxtecan. In this BLA, the companies are looking to get FDA’s approval for the candidate as a potential treatment for HER2-positive metastatic breast cancer (“MBC”). With the FDA granting priority review, a decision is expected in the second quarter of 2020.

We remind investors that AstraZeneca acquired joint development and commercialization rights to this promising cancer candidate from Japan’s Daiichi Sankyo in April this year for approximately $6.9 billion.

The BLA was filed based on the combination of data from pivotal phase II DESTINY-Breast01 study and a phase I study. The phase II study evaluated trastuzumab deruxtecan in HER2-positive unresectable and/or metastatic breast cancer patients who have received prior treatment with Roche’s (RHHBY - Free Report) Kadcyla (trastuzumab emtansine).

Previously announced data from the phase I study demonstrated that treatment with trastuzumab deruxtecan achieved a complete response rate of 59.5% and median duration of response of 20.7 months in HER2-positive MBC patients. Median progression-free survival was 22.1 months. An independent review of the response rate achieved in the DESTINY-Breast01 study validated the clinical activity observed in the phase I study. Detailed data from this pivotal study will be presented at the San Antonio Breast Cancer Symposium in December.

Trastuzumab deruxtecan enjoys both Breakthrough Therapy Designation and Fast Track designation.

AstraZeneca’s stock has rallied 13.1% this year so far compared with the industry’s rise of 0.3%.

AstraZeneca and Daiichi Sankyo equally share development and commercialization costs of trastuzumab deruxtecan. Daiichi, however, retained exclusive rights to the drug in Japan. Daiichi submitted a regulatory application last month seeking approval for the candidate for treating HER2-positive MBC in Japan.

Apart from breast cancer, trastuzumab deruxtecan is also being developed to treat other HER2-expressing cancers including gastric cancer, advanced colorectal cancer and lung cancer.

Zacks Rank & Stocks to Consider

AstraZeneca currently carries a Zacks Rank #3 (Hold). Some better-ranked large cap drug stocks are GlaxoSmithKline (GSK - Free Report) and AbbVie (ABBV - Free Report) . Both the companies carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Glaxo’s shares have risen 11.1% this year so far. Its earnings estimates for 2019 have gone up 2.1% in the past 30 days. Though AbbVie’s shares have declined 4.7% this year, its earnings estimates have increased 0.3% for 2019 over the past 30 days.

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